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Hindawi Publishing Corporation Evidence-Based Complementary and Alternative Medicine Volume 2011, Article ID 382961, 8 pages doi:10.1093/ecam/nep048 Review Article Looking for a Person-Centered Medicine: Non Conventional Medicine in the Conventional European and Italian Setting Paolo Roberti di Sarsina 1 and Ilaria Iseppato 2 1 Italian High Council of Health, Ministry of Health, Rome, Italy 2 Department of Sociology, University of Bologna, Bologna, Italy Correspondence should be addressed to Paolo Roberti di Sarsina, [email protected] Received 1 December 2008; Accepted 9 April 2009 Copyright © 2011 P. R. D. Sarsina and I. Iseppato. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In Italy, the use of non conventional medicines (NCMs) is spreading among people as in the rest of Europe. Sales of alternative remedies are growing, and likewise the number of medical doctors (MDs) who practise NCM/complementary and alternative medicine (CAM). However, in Italy as in other countries of the European Union, at the present time the juridical/legal status of NCM/CAM is not well established, mainly due to the lack of any national law regulating NCM/CAM professional training, practice and public supply and the absence of government-promoted scientific research in this field. This is an obstacle to safeguarding the patient’s interests and freedom of choice, especially now that dissatisfaction with biomedicine is inclining more and more people to look for a holistic and patient-centered form of medicine. 1. Introduction In western societies, people generally confuse the terms “medicine”, “biomedicine”, “evidence-based medicine” and “allopathic”, using them as synonyms. Though the neologism “biomedicine” appeared as early as 1923 in Dorlands Medical Dictionary [1]—defined as “clinical medicine based on the principles of physiology and biochemistry”—neither this nor other specific hybrid meanings were much heard of before the 1960s when the US National Institutes of Health (NIH) introduced the term to justify its diversion of funds into molecular biology. “Medicine” proper is actually something more comprehensive, a holistic concept that includes “biomedicine”, but also all other philosophi- cal/anthropological approaches to managing health, illness and disease. Amid the prevailing confusion, western biomed- ical culture tends in its turn to define “alternative medicine” in a negative way, as something outside the mainstream, unsupported by scientific explanation or academy legitimiza- tion [2]. 2. The National Center for Complementary and Alternative Medicine The National Center for Complementary and Alternative Medicine (NCCAM) of the US NIH defines CAM as a broad domain of healing resource that encompasses all health systems, practices and beliefs, other than those intrinsic to the politically dominant health system in a particular society at a given historical period. The main limitation of this definition is mixing alternative medicine and comple- mentary practices in one single category. CAM has been defined as therapeutic intervention that has neither been widely established for use in conventional healthcare practice nor incorporated into the standard medical curriculum. The NCCAM characterizes CAM therapies into five categories: biologically based therapies, manipulative- and body-based therapies, energy medicine, mind-body medicine and whole medical systems. In contrast, we have the definition of tra- ditional medicine issued by the World Health Organization (WHO) which states that traditional medicine is the sum

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Page 1: LookingforaPerson-Centered Medicine ...NCM practices and people are increasing their expenditure year by year on NCM/CAM medicines, therapies and practices. Even the number of NCM/CAM

Hindawi Publishing CorporationEvidence-Based Complementary and Alternative MedicineVolume 2011, Article ID 382961, 8 pagesdoi:10.1093/ecam/nep048

Review Article

Looking for a Person-CenteredMedicine: Non Conventional Medicine inthe Conventional European andItalian Setting

Paolo Roberti di Sarsina1 and Ilaria Iseppato2

1 Italian High Council of Health, Ministry of Health, Rome, Italy2 Department of Sociology, University of Bologna, Bologna, Italy

Correspondence should be addressed to Paolo Roberti di Sarsina, [email protected]

Received 1 December 2008; Accepted 9 April 2009

Copyright © 2011 P. R. D. Sarsina and I. Iseppato. This is an open access article distributed under the Creative CommonsAttribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work isproperly cited.

In Italy, the use of non conventional medicines (NCMs) is spreading among people as in the rest of Europe. Sales of alternativeremedies are growing, and likewise the number of medical doctors (MDs) who practise NCM/complementary and alternativemedicine (CAM). However, in Italy as in other countries of the European Union, at the present time the juridical/legal status ofNCM/CAM is not well established, mainly due to the lack of any national law regulating NCM/CAM professional training, practiceand public supply and the absence of government-promoted scientific research in this field. This is an obstacle to safeguarding thepatient’s interests and freedom of choice, especially now that dissatisfaction with biomedicine is inclining more and more peopleto look for a holistic and patient-centered form of medicine.

1. Introduction

In western societies, people generally confuse the terms“medicine”, “biomedicine”, “evidence-based medicine” and“allopathic”, using them as synonyms. Though the neologism“biomedicine” appeared as early as 1923 in Dorland’s MedicalDictionary [1]—defined as “clinical medicine based onthe principles of physiology and biochemistry”—neitherthis nor other specific hybrid meanings were much heardof before the 1960s when the US National Institutes ofHealth (NIH) introduced the term to justify its diversionof funds into molecular biology. “Medicine” proper isactually something more comprehensive, a holistic conceptthat includes “biomedicine”, but also all other philosophi-cal/anthropological approaches to managing health, illnessand disease. Amid the prevailing confusion, western biomed-ical culture tends in its turn to define “alternative medicine”in a negative way, as something outside the mainstream,unsupported by scientific explanation or academy legitimiza-tion [2].

2. The National Center for Complementary andAlternative Medicine

The National Center for Complementary and AlternativeMedicine (NCCAM) of the US NIH defines CAM as a broaddomain of healing resource that encompasses all healthsystems, practices and beliefs, other than those intrinsicto the politically dominant health system in a particularsociety at a given historical period. The main limitation ofthis definition is mixing alternative medicine and comple-mentary practices in one single category. CAM has beendefined as therapeutic intervention that has neither beenwidely established for use in conventional healthcare practicenor incorporated into the standard medical curriculum. TheNCCAM characterizes CAM therapies into five categories:biologically based therapies, manipulative- and body-basedtherapies, energy medicine, mind-body medicine and wholemedical systems. In contrast, we have the definition of tra-ditional medicine issued by the World Health Organization(WHO) which states that traditional medicine is the sum

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2 Evidence-Based Complementary and Alternative Medicine

total of indigenous knowledge used in the maintenance ofhealth; without distinction the concept extends to CAM,NCM, holistic medicine and natural medicine. Such termsare used interchangeably with traditional medicine in somecountries and refer to a broad set of health care practices thatare not a part of that country’s own tradition and are notintegrated into the dominant health care system.

3. Other Definitions

Paradoxically, then, in western countries indigenousbiomedicine and alternative medicine may come to coincide.We thus have a preference for NCM: this term is scientificallyneutral and alludes to the conventional status appropriatedby biomedical orthodoxy [3]. That NCM may be the firstchoice of people looking for well-being and health, and isnot necessarily posited against the dominant paradigm [4].The term has also been adopted by the European Parliamentin its Resolution n. 75 issued on May 29, 1997 that deals with“The Status of NCM”.

Now, ∼80% of the world’s population uses traditional,complementary and alternative, NCM; 50% of all drugsapproved were from 1981 to 2002 and 62% of anti-cancerdrugs are derived from natural products. According to theWHO, more than half of the European citizens have usedNCM practices and people are increasing their expenditureyear by year on NCM/CAM medicines, therapies andpractices. Even the number of NCM/CAM practitioners isincreasing in all countries of the European Union (EU).Many MDs and medical students share their patients’uncertainty about conventional medicine and over the last15 years have moved from a position of silent interest to oneof open inquiry and growing use [5–11], while an increasingnumber of organized professional groups are institutingappropriate education and training.

The right of choice that today’s individuals have concern-ing their own state of health and illness has often been statedand has taken concrete shape with increasingly large sectionsof the population resorting to treatments and therapeuticpractices known under the umbrella: “NCMs” or “CAM”(NCM/CAM), that is, not yet integrated into the dominanthealth care system.

4. The WHO

The WHO has always promoted traditional, complementaryand alternative, NCMs. Again, the seventh FrameworkProgramme of the European Community for research, tech-nological development and demonstration activities (2008–13) identifies successful interventions in complementary andalternative medicine for safeguarding and improving thehealth of European citizens and, indirectly, their right ofchoice [12]. Here is the policy statement on this point runs:

The Programme should recognize the importanceof a holistic approach to public health and takeinto account, where appropriate and where thereis scientific or clinical evidence about its efficacy,

complementary and alternative medicine in itsactions (European Parliament, 23.10.2007).

According to the Italian Institute for Statistics [13], in2005 ∼8 million persons in Italy had used NCMs during theprevious 3 years: the typical Italian user of NCM/CAM is anadult between 35 and 44 years of age with post-high schoolqualifications; there are a greater percentage of women;and the most used NCMs and therapies are: homeopathy,acupuncture, herbal remedies, anthroposophic medicine andchiropractic. Most users admit to having gained great orhealing without side effects.

There are many explanations for the progressive diffusionof NCM/CAM therapies, which have much to offer, partic-ularly in the absence of effective conventional approaches.Biomedicine once served to make patients better, alleviatingsymptoms and healing disease; now, some think it hasdegenerated into a risk-reducing, patient-stratifying, life-years-adding bioscience disregarding individual needs [14].Currently, it seems that NCM/CAM can often be used asa first option in certain problems, keeping more costly,invasive and potentially toxic treatment as a second option.It may help to prevent often long-term dependency onbiomedical medication and to reduce the enormous burdenof mortality and morbidity caused by the iatrogenic effectsof allopathic prescription drugs, peoples’ ever increasingresistance to antibiotics and the inability of biomedicaldrugs and therapies to cope with chronic and psychosomaticdiseases.

Current citizen attitudes to health include a preferencefor natural products instead of chemical drugs, a holisticsustainable philosophy and related behavior in terms ofhealth management, a belief in individual responsibility forachieving wellness, more attention to relationship, dialogueand emotive needs, less unquestioning acceptance of med-ical authority and anti-technology feelings. Many of thesearguments have been explored in the recent literature, andRoberti di Sarsina [15] emphasizes a more person-centered,humanized, personalized approach to medicine based onrespect for people’s whole bio-psycho-spiritual unity andequilibrium, including their relation to the environmentand the way they perceive or “narrate” their own complexindividual existence, in sickness and in health. Other works,including several geared to the Italian situation, add to thepicture of current trends and perspectives [16–19].

5. Diffusion of NCM/CAMPatients and Practitioners

In Europe, in spite of the increasing stringency of rulesintroduced by pharmaceutical agencies and European legis-lation, since 2003 the economic importance of homeopathicand anthroposophic medicinal products has increased by20% in response to the demands of millions of Europeancitizens [20]. In Italy, today there are almost 3000 MDs usingacupuncture, more than 8000 homeopaths, about 20 000MDs with homeopathic training and approximately 160MDs who have completed the 3-year residential course onanthroposophic medicine. All these numbers are increasing,

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Evidence-Based Complementary and Alternative Medicine 3

in line with European trends. NCM/CAM practitionersare joining forces in organizations designed to enhancecredibility and to establish standards of practice. Almostone chemist’s shop in two offers homeopathic remedies.In Italy there are 30 homeopathic laboratories, large orsmall, creating more and more job opportunities. Accordingto ECHAMP (the European Coalition on Homeopathicand Anthroposophic Medicinal Products), the Europeanturnover of homeopathic products was 810 million eurosin 2007. Three out of the four Europeans know abouthomeopathy and of these 29% use it for their own healthcare. This represents 100 million Europeans.

The geographical distribution of homeopathic remediesin Italy is the following: 50% in the north, 35% in thecenter, 15% in the south and islands. In 1980, 2000 chemist’sshops out of the 14 365, that is 14%, had a section forhomeopathic remedies. By 2000, 7000 chemist’s shops outof the 16 000, that is 43%, had a section for homeopathicremedies. In 2005, Italy was the third European country afterFrance and Germany for sales of HAMP (Homeopathic andAnthroposophic Medicinal Products). About 49% of French,46% of Germans and 35% of British use NCMs.

According to an ISTAT (Italian National Institute forStatistics) survey 2007 (relating to the year 2005) [13], 13.6%of Italians use of NCM: 4.7 million women (15.8% of Italianwomen), ∼3.2 million men (11.2%), ∼10% of the children.Most users belong to the higher social classes and live innorth Italy. Among the various NCM/CAM, homeopathyproved the most common. A marked connection persistingin time is consolidated between users of such therapy andhigher education. It also means that 5 years on from theprevious ISTAT poll (1999) no less than 8 million Italiansconfirmed the worth and utility of such treatment.

The economic burden on families is another factor to beconsidered. As its purchasing power has been whittled awayrecently, the family budget is increasingly onerous to coverfull costs of non-conventional health (doctor, medicinesand supplementary therapy). It is workers whose categoriesrefund such treatment (e.g., journalists, managers, etc.)that heads the list of users statistically. More and morefrequently one hears cases of families where the parentsreserve alternative treatment for their children and cannotafford it for themselves.

There are over 20 000 Italian practitioners prescribinghomeopathic and anthroposophic medicines. Many aredoctors and veterinarians who have done years of post-graduate training to acquire specific skills in homeopathy,anthroposophic medicine and homotoxicology, which arethe three sectors that use homeopathic medication. Home-opathic and anthroposophic medicines are found exclusivelyat most Italian chemist’s shops. Homeopathic medicine existsfor >200 years and in Italy offers a range of more than 5000medicines. Italy has about 30 homeophatic companies andthese together employ more than 1200 persons.

Italy is the third European market after France andGermany with HAMP sales (Figures 1 and 2) and the seventhEuropean country by HAMP consumption per head. At least10% of Italians use homeopathic remedies (i.e., medicalremedies produced with respect to relevant pharmacopeias

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Figure 1: Top 10 European countries by HAMP consumption perhead in C (source: ECHAMP, 2007).

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Figure 2: European sales of HAMP by country 2005 (source:ECHAMP, 2007).

through dilution and dynamization processes, regardlessof clinical technique applied to choosing and prescribingthe remedy in homeopathy, homotoxicology and anthropo-sophic medicine). The typical Italian user of homeopathy,homotoxicology and anthroposophic medicine tends to bean adult between 35 and 44 years of age with post-highschool qualifications. The patients (70%) admit to havinghad benefits without side effects from the three remedies. In2007, Italians spent some 300 million euros on homeopathicmedicines. Via IVA, IRES and IRAP the State levy for 2007was 40 million euros. Since neither homeopathic therapy norexamination by homeopaths is a burden on the state budget,homeopathy thus brings in net revenue of 40 million euros,less the saving on doctors’ consultations.

6. Other Recent Surveys

A survey carried out in 2003 by ABACUS (institute formarketing research and opinion surveys) reveals us that 30%of Italians made regular use of NCM/CAM with good results.In the same year, DOXA (institute for statistical research andpublic opinion analyses) revealed that 23% of Italians, that is,11.5 million people, consulted homeopathic MDs. The sameresult was confirmed by EURISPES (Institute for political,economical and social studies) in 2006. A survey carried outby FORMAT (Institute for marketing research) on a samplegroup of 864 people and published in “Salute di Repubblica”

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4 Evidence-Based Complementary and Alternative Medicine

(a weekly insert of the Italian daily La Repubblica) no. 284of November 27, 2003 shows that 31.7% had used someform of NCM/CAM in the previous 3 years (23.4% in theprevious year) with stable and constant benefits. Six Italiansout of the 10 think that non-conventional products areeffective and 45.6% find it right that the National HealthSystem should pay for them. Nonetheless, only 27.8% ofthose interviewed knew that nine NCM/CAM (homeopathicmedicine, phytotherapy, acupuncture, homotoxicology, tra-ditional Chinese medicine, anthroposophic medicine, chiro-practic, osteopathy and ayurvedic medicine) are recognizedby the National Association of Medical Doctors and Dentists.

In 2003, a poll was carried out by the Tuscan RegionalHealth Agency to learn the opinions of general practitionersand pediatricians about NCM/CAM. Two of almost 3500physicians (2228) interviewed (82% answers registered) hadthe following results: 15.2% use NCM/CAM; 57.8% advisetheir patients to use NCM/CAM; 11% have been specificallytrained for NCM/CAM; 29.2% wish to be trained; 65.7%approve that NCM/CAM should be taught at the university;23.7% have used NCM/CAM to treat their own healthproblems. Sixty-two per cent of the patients inform theirgeneral practitioner that they use NCM/CAM.

A study carried out on a sample of 52 332 families, toa total number of 140 011 people, and published in 2004by Menniti-Ippolito and colleagues [21] in the Annals ofthe Italian National Institute for Health, reports that atleast 15.6% of Italians used NCM/CAM over a 3-year span(homeopathy 8.2%, manual treatments 7.0%, phytotherapy4.8%, acupuncture 2.9% and other NCM/CAM 1.3%).Another poll was commissioned by the monthly Italianmagazine “Natural Style” from S&G Kaleidos Group ofMilan and published in the December 2004 issue dealingwith the diffusion of NCMs in Italy. The survey, performedon a sample of 500 women and men between 18 and 54years of age, reveals that 40.8% consider NCM/CAM betterthan official medicine. The main reasons for choosing softtherapies are: lack of side effects (31.8%), possibility to cureoneself by restoring physical and psychic balance (27.6%),to live in a healthier way (16.9%) and to get back to nature(12.5%).

Yet, another recent survey was presented during the2005 Erbexpo Edition held at Carrara in Tuscany. It tookthe form of a web poll coordinated by the team of Prof.Benigno Passagrilli, the President of the Scientific Committeeof Erbexpo 2005. The identikit of the Italian NCM/CAMuser is described as follows: a woman, 45 years of age,working as an employee and living in the center northapproaches NCM/CAM because she shares the philosophy,tries to convince the whole family to use herbs, infusions,acupuncture and other non-conventional techniques. Thesurvey collected 1177 answers. The result is that more women(62%) than men (38%) use NCM/CAM. The age rangesfrom 30 to 60 years. In particular, 30% are between 30and 50 years old and 35% between 50 and 60 years. Theelderly (60- to 70-years old) people are the least interestedin the new medicines (15%), whereas the youngest aremore enthusiastic users (20% between 20 and 30 yearsof age). With regard to professions, the majority of the

1177 interviewed are employees (28%), followed by retiredpeople (27%). Self-employed people accounted for 17%,businessmen 11%, craftsmen 10% and other professions7%. The survey also reveals that the use of complementaryremedies involves the whole family: 68% of the people statethat all the members of the family use them, in 22% of thecases only the wife, in 7% of the cases only the husbandand in 3% of the cases the children. Such answers hintthat on the one hand there is a strong motivation to takepart in this type of poll when the family has a specificculture for natural products, and on the other hand that thechildren are not involved when such a background is missing.The answers suggest that the results of complementarytherapies are considered good (65%), satisfactory (20%)and unsatisfactory (15%). The lack of satisfaction mightindicate poor preparation on the part of the MD dealingwith the patient (in Italy, we still await a law to regulate thetraining of medical and non-medical operators), or too highexpectations by patients, due to wrong information.

By what pathways do people come to complementarymedicine? Mere curiosity (21%) shares the same philosophy(48%), a desire to escape from official medicine (31%). Thispattern of interest might again be read as the result of a baddoctor-patient relationship, or as anxiety about the chemicalworld. With regard to the information given out by the massmedia, 60% of those interviewed think it is enough, 25%would like to have more and 15% consider it inadequate.Finally, an open poll proposed in two languages (Italian andEnglish) on line by Cyber med, an online journalistic medicalsite, from March 2006 to September 2008 collected 87.7%of votes in favor of NCM/CAM being included in third-party insurance payment and 76.2% of votes in favor ofNCM/CAM coming into the national health care system.

Looking at the data, the need for more political attentionto the social demand for NCM/CAM and to the problem ofregulating NCM/CAM practice becomes evident, not onlyto protect patients’ safety and their right to choose how totake care of themselves, but also to prevent the rise of newsocial and geographical inequalities in the access to non-conventional therapies (Table 1). NCM/CAM should notremain an opportunity for the educated and rich alone butmust be known and made accessible to everyone who wantsto experiment ways differing from biomedicine.

7. Legal Status of NCM/CAM and the Need forAccredited Training

7.1. European Parliament. According to Ton Nicolai, Presi-dent of the European Committee for Homeopathy (ECH),speaking at the European Public Health Alliance (EPHA)Conference (Bratislava, April 2007) [22], in 15 EU coun-tries large numbers of general practitioners refer patientsfor NCM/CAM treatment and have a significant interestin training and information on NCM/CAM. Moreover,according to the European Coalition on Homeopathic andAnthroposophic Medicinal Products (ECHAMP), ∼1% ofall medical doctors and 40% of general practitioners in theEuropean Union have taken training courses in a particular

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Evidence-Based Complementary and Alternative Medicine 5

Table 1: Results of most recent research in Italy.

ISTAT (Italian National Institute for Statistics) (1996–99): 9million (15.5%)

ABACUS (Institute for Marketing Research and Opinion Sur-veys) (2003): 30% population

DOXA (Institute for Statistics Research and Public OpinionAnalyses) (2003): 23% population

ISPO Research Institute (2003): 65% familiar with the termNCM/CAM and know about them

FORMAT (Institute for Marketing Research) (2003): 31.7% useNCM/CAM at least once; 23.4% use NCM/CAM regularly

CENSIS (Centre for Social Researches) (2003): ∼50% considerNCM/CAM useful; >70% ask for National Health Systemreimbursement; 65% want more control by national healthauthorities

Menniti-Ippolito et al. [21]: 3 year follow-up of 52 332 families(140 011 people), use of NCM/CAM by Italian population:15.6% (homeopathy 8.2%, manual therapies 7.0%, phytother-apy 4.8%, acupuncture 2.9% and other NCM/CAM 1.3%)

ISTAT (Italian National Institute for Statistics) (2005): 8 million(13.6%) population

EURISPES (Institute for Political, Economical and SocialStudies) (Rapporto Italia 2006): 11 million use homeopathicmedicine

CENSIS (Centre for Social Researches) (2008): 23.4% have usedNCM/CAM during the previous year (especially homeopathyand phytotherapy)

NCM/CAM therapy. There are professorial NCM/CAMchairs at universities in Germany, Italy, Spain, Switzerlandand the UK; however, postgraduate training courses are stillheld mostly at private teaching centers. Various professionalNCM/CAM doctor associations (ECH, ICMART and IVAA)have established training standards and accredited trainingcourses that comply with those standards. In some EUcountries, MDs can obtain specific additional qualificationsin NCM/CAM issued by the national medical associations(Austria, Germany, Latvia and Romania), while in othercountries the national medical associations are in favor ofstatutory regulation of CAM for physicians (France, Greece,Italy and Spain) [23–26].

The European Parliament (1997), the Council of Europe(1999) and the WHO (2003, 2008) have all passed reso-lutions calling on Member States to recognize professionalqualifications and to start a national policy on NCM/CAM,but today only seven out of the 27 EU Member States haveissued national policies on NCM/CAM. Some countries suchas Italy regulate certain specific NCM/CAM therapies; othercountries have no national policy on NCM/CAM at all. Inany case, the situation remains unsatisfactory because of thefailure to standardize legal status and training rules amongthe States [27, 28].

8. The Italian Republic

The Italian Republic protects health as a fundamental rightof the individual, safeguards the principle of scientific

pluralism and ensures that the individual be free to choosetreatments and that health operators professionally qualified,with special focus on the independence of MDs as regardsthe choice of treatment (Suprema Corte di Cassazione, theItalian Supreme Court of Justice, 4th Section, Sentence no.301, February 8, 2001). Italy has a national health serviceestablished in 1978 to provide uniform and comprehensivecare financed by general and regional taxation (97%) andpatient co-payments [29]. Under the Italian Constitution,responsibility for healthcare is shared by the State and the20 regions; the State sets healthcare standards known asLivelli Essenziali di Assistenza (LEA)s which apply as ofright to all residents throughout the country, while regionshave responsibility for organizing and administering publicfunds (hence the many regional disparities in fiscal capacity,distribution of public facilities and appropriateness of care).

In 2002, resolution 1206 of the Council of Europe,November 4, 1999, concerning the status of NCM/CAMspurred the National Federation of Medical Doctors andDentists (FNOMCeO) to action. By the so-called TerniResolution, entitled “Guidelines on Non ConventionalMedicines and Practices”, nine NCM/CAM were recog-nized: acupuncture, traditional Chinese medicine, ayurvedicmedicine, homeopathy, anthroposophic medicine, homo-toxicology, phytotherapy, chiropractic and osteopathy. Theseare deemed to fall exclusively under the professional respon-sibility of medical doctors and dentists; they are “to all effectsmedical practice”. In the Professional Code of Medicine, anarticle (Art. 15) is devoted to NCMs. It reads as follows:

Recourse to non-conventional practices forms aninseparable part of the profession’s decorum anddignity and belongs exclusively to the direct non-delegable professional responsibility of the doctor.

Recourse to non-conventional practices must notdivert the citizen from specific, scientifically con-solidated therapies and always calls for properlyinformed consent. Doctors are forbidden to collab-orate in any way with, or promote the practice of,third parties not of doctor status in the sector ofso-called non-conventional practices.

A similar resolution was passed in 2003 by the ItalianFederation of Veterinarians (FNOVI). The range of disci-plines accorded proper veterinary status, the definition ofresponsibility by qualified professionals and the implicationsfor other practitioners are to all effects the same. On October20, 2003, within the 43rd National Congress of the ItalianSociety of Psychiatry the first Consensus Conference ofNCM/CAM in Italy was promoted, organized and chairedby Paolo Roberti di Sarsina, and a related first ConsensusDocument on NCM/CAM in Italy was signed by the mostimportant associations of NCM/CAM [30]. On December5, 2003, Roberti di Sarsina was instrumental in constitutingthe Permanent Committee of Consensus and Coordinationfor NCM/CAM in Italy chosen from among signers of theConsensus Document, with himself as coordinator. All thesignatories hoped that this event would stimulate fullerintegration of similar initiatives in the field of so-called basicmedicine and in other fields of medical specialization.

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6 Evidence-Based Complementary and Alternative Medicine

The Government and the Parliament have been invitedto pass a law acknowledging and regulating the practiceof NCM/CAM. No such law has yet been passed. Duringthe last 20 years, some 20 draft bills about NCM/CAMhave been tabled without results. It can be said that Italianinstitutions have not yet responded to public demand;similarly, knowledge of NCM/CAM among MDs, especiallygeneral practitioners, is not as widespread as patient demandwould require [31–34].

What little has been done is extremely cautious and attimes even contradictory. The Supreme Court (Cassazione)has ruled (1982, 1999, 2003, 2005, 2007) that acupunctureis a medical practice; that whoever prescribes homeopathicproducts must be a doctor; that it is an abuse of themedical profession for anyone to practice NCM/CAM ifthey have not attained a degree in medicine. The SupremeCourt clarified once and for all that public health is tobe safeguarded, ruling that all NCM/CAM may only bepracticed by doctors. Practice is thus subordinate to proof ofattainment of the state qualifying examination, membershipof the professional roll and possession in the first place of adegree in medicine.

The Constitutional Court (2005–08) has ruled thatRegions may not pass laws on the recognition of professionalfigures or establishment of new rolls; these offices arereserved for the State. On the question of the constitutionallegitimacy of regional legislation to regulate professionalactivity, the Constitutional Court ruled that such regionallegislative power in matters pertaining to the “professions”must abide by the principle whereby the recognition ofprofessional figures and respective qualifications is reservedfor the State for necessary reasons of uniformity; it falls to theregions to discipline features that have a specific connectionwith the region itself. This principle applies not only toestablishing particular specific norms, but also as a generallimit beyond which regional law may not step. It thus followsthat such laws as have been submitted for approval by theLaw Judge are constitutionally illegitimate.

In 2006, Italy received the European Directive on Drugs2004/27/CE that contains five specific articles on homeopa-thy and anthroposophic medication taking account of thepeculiar production and control features relating to these twoclasses of drugs. That the Italian government has receivedthe Directive means, at least, that such homeopathic andanthroposophic drugs as exist on the Italian market arelegitimate until 2015. There is, however, an unaccountablefailure as yet to introduce a series of norms to safeguardthe citizen. For example, there is a law (which only Italypossesses) that bans printing instructions and dosages onthe packet (to the serious detriment of the consumer).Another incredible fact: for many years, new homeopathicmedicines have not been authorizable. Ever since 1995,the administrative procedure for registering new drugs hasbeen in abeyance. Even publicizing homeopathic remediesis banned in any form, which clears further evidenceof discrimination. After the procrastination for 20 years,Parliament is therefore urged to legislate without furtherdelay and approve a full-scale national law on NCMs. InApril 2009, the AIFA (the Italian drug agency) issued the

first guidelines on the quality of homeopathic products,improving in this way the therapeutic opportunities even interms of pharmacoeconomy [35].

Meanwhile, one obvious implication of state recognitionfor the practice of NCM/CAM as a medical act is thatthe State itself should promote professional training andprovide information for students of university faculties suchas medicine and surgery, veterinary studies, dentistry andall other connected faculties. There should also be post-graduate training with specialization courses or masterssimilar to those already existing in several Italian universities(Milan, Palermo, Rome, L’Aquila, Chieti, Brescia, Florence,Pisa, Verona and Bologna). The State should also acknowl-edge the training activity carried out during recent years byprivate associations and schools in this sector. It should bestressed that this kind of higher education, based on holisticparadigms and philosophies, not only regards methods andpractices, but also addresses the human relationship betweendoctor and patient and seeks to improve the personalizationof care.

According to the Parliament, the most important thingis to guarantee patients the possibility to choose non-conventional therapies, by providing accurate and completeinformation, thus allowing free choice of individual healthpaths. On March 19, 2008, the Italian Ministry of Healthsigned a ministerial decree including NCMs among themedical practices covered by integrative insurance funds.These public funds are to cover NCM/CAM services thatare not included among the LEAs (basic welfare levels) ifprovided by public or private accredited structures actingofficially on behalf of the National Health Service.

9. Regional Initiatives

Important initiatives have recently been taken by manyregions after the reform of Clause V of the Italian Constitu-tion, to the effect that the Regions should bear joint legislativejurisdiction with regard to the “professions”. Since the lack ofa national law governing NCM/CAM makes access to thesepractices unequal [36], some regions such as Tuscany haveincluded a chapter on NCM/CAM in their regional healthplans: acupuncture is guaranteed as an approved regionalLEA, patients are to pay a basic contribution for homeopathy,phytotherapy, acupuncture and traditional Chinese medicineservices, and these are already available in 63 regional welfarecenters at specially low-controlled prices.

9.1. Italian Regions. In Campania by resolution no. 3589dated December 2003 and with Guidelines as to theallocation of research funds and the form of support bythe ASLs (local health agencies, public enterprises thatare legally offshoots of the region) and by private centersalready operating in the regional territory (D.P.G.R. no. 1182dated 15/11/2001), the Region allocated a restricted fund of3 000 000 euros to NCM/CAM, which was later increasedto 4 000 000. The fund covered NCM/CAM services offeredas Basic Levels of Regional Assistance (LEAs) and trainingactivity on NCM/CAM.

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Evidence-Based Complementary and Alternative Medicine 7

In the Emilia-Romagna Region, resolution no. 297 datedFebruary 23, 2004, established an official health boardRegional Observatory for NCM/CAM responsible for settingup and promoting experimental projects to be run by theLocal Health Agencies, focusing in particular on acupunc-ture, homeopathy and phytotherapy, the aim being to findsolutions for the integration of NCMs within biomedicine.In 2006, the Region of Emilia-Romagna sent Parliament aproposed national bill to regulate CAM. This is the first timean Italian Region has used the prerogative foreseen by art.121 Comma 2 of the Italian Constitution.

Umbria focuses on training for MDs who practiceNCM/CAM in public surgeries and has defined specific tar-iffs and access pathways. With a slightly different emphasis,the Lombardy Region’s past “legislatures” have seen morethan 10 experimental and observatory studies and clinicalaudits on NCM/CAM, promoted by both public services andprivate institutes in collaboration with the WHO, which havenow reached the operating stage.

9.2. Italian Perspectives. Despite these positive signals, inItaly there is still no mature culture of NCM/CAM orany shared awareness of the steps that should be taken toregulate this world. In the absence of national regulations,the Regions do not act uniformly or promote action leadingto harmonization of decisions and behavior. Until theItalian Parliament issues a national law on NCM/CAM, theregions are the main actors in the process of management,authorization and recognition of NCM/CAM in Italy.

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